[424] Value of p16/Ki67 Dual Immunostaining Evaluation of Cervical Cytology Specimen

Leonardo Rodriguez-Carunchio, Victoria Fuste, Tatiana Benavides, Paola Castillo, Agata Rodriguez, Immaculada Alonso, Aureli Torne, Marta del Pino, Jaume Ordi. Hospital Clínic - CRESIB (Centre de Recerca en Salut Internacional de Barcelona), Barcelona, Spain; Hospital Clínic - Institut d´Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

Background: Early diagnosis of cervical cancer is based on the detection of high-grade cervical intraepithelial neoplasia (CIN2-3). Although conventional cytology has a high diagnostic specificity has a poor sensitivity. On the other hand, molecular techniques of detection of hr-HPV markedly improve sensitivity but significantly reduce the specificity. It has recently been proposed that the use of p16/Ki67 dual immunostaining in cytological specimens could improve the accuracy of these tecniques. The main objective of this study is to assess the sensitivity and specificity of p16/Ki67 dual staining and compare it with the results of VPH detection using Hybrid Capture 2 (HC2).
Design: From October 2009 to July 2011, 527 women were included in the study (mean age: 35.8±10.9 years). All of them were referred to the colposcopy unit of the Hospital Clinic of Barcelona due to abnormal cytology results. Digital colposcopy, liquid-based cytology specimen (ThinPrep®), hr-HPV detection using HC2 (Qiagen) were obtained in all cases, and colposcopically directed biopsy and/or endocervcial curettage when clinically indicated. p16/ki67 dual immunostaining in cytology (CINtec plus, mtm) were performed in all cases. Definitive diagnosis was established after a complete study of the patients.
Results: After the completion of the study, 227 patients (43.1%) were classified as CIN2+, 153 (29.0%) as CIN1 y 147 (27.9%) as negative. A positive result for the dual immunostaining were detected in 91.6% of CIN2+, 51.6% of CIN1 and 6.8% of of the women with a negative study. A HC2 positive test was observed in 96.5% of CIN2+, 90.8% of CIN1 and 49.8% of the women with a negative study. The sensitivity, specificity, positive and negative predictive values for the identification of CIN2-3 of dual staining and HC2 are shown in table 1.

Table 1
 SensitivitySpecificityPositive predictive valueNegative predictive value
Hr-HPV (HC2)96.5%29.7%50.9%91.8%
P16/Ki67 dual staining91.6%70.3%70.0%91.7%



Conclusions: p16/Ki67 dual staining presents a sensitivity similar to HC2 with higher specificity values and could be used as complementary tool for conventional cytology and/or HC2 for diagnosis and follow-up of CIN2-3.
Category: Cytopathology

Tuesday, March 20, 2012 9:30 AM

Poster Session III # 39, Tuesday Morning

 

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